PARAMETRIC STERILITY RELEASE OF AUTO— 510(k) K830741

Substantially Equivalent

United Surgical Corp.

FDA 510(k) clearance K830741 for PARAMETRIC STERILITY RELEASE OF AUTO, Substantially Equivalent on 1983-08-11. Applicant: United Surgical Corp..

Clearance details

Applicant: United Surgical Corp.
Product code: Code GAG
Advisory panel: General Hospital
Date received: 1983-03-08
Decision date: 1983-08-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, US

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Adverse events under product code GAG

product code GAG

Death: 23
Injury: 394
Malfunction: 2,304
Other: 6
Total: 2,727

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.